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Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy

H

Hospital Clinic of Barcelona

Status

Completed

Conditions

Endometriosis Ovary

Treatments

Procedure: CO2 (carbon dioxide) laser vaporisation
Procedure: Stripping technique

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.

Enrollment

16 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18 and 45.
  • Bilateral endometriomas.
  • Endometrioma size > 3 cm.
  • Pain and/or infertility as indication to surgical treatment.

Exclusion criteria

  • History of cancer.
  • Suspected malignancy.
  • Evidence of premature ovarian failure.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

16 participants in 2 patient groups

Stripping technique
Active Comparator group
Description:
The endometrioma is removed according to standard surgery.
Treatment:
Procedure: Stripping technique
Laser technique
Experimental group
Description:
The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser
Treatment:
Procedure: CO2 (carbon dioxide) laser vaporisation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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